ASD-STAN PREN 9137-2010 Quality management systems Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System (Edition P 1)《质量管理体系 AQAP2110在EN 9100质量管理体系.pdf

1、ASD STANDARD NORME ASD ASD NORM prEN 9137 Edition P 1 March 2010 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONAvenue de Tervuren, 270 - B-1150 Brussels - Tel. 32 2 775 8126 - Fax. 32 2 775 8131 - www.asd-stan.orgICS: Descriptors: ENGLISH VERSION Quality ma

2、nagement systems Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System Systmes de management de la qualit Guide pour lapplication de lAQAP 2110 dans un Systme de Management de la Qualit EN 9100 Qualittsmanagementsystems Anleitung fr die Anwendung von AQAP 2110 in eine

3、m EN 9100 Qualittsmanagementsysteme This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically app

4、roved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examina

5、tion and review by users and formal agreement of ASD-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national le

6、vel by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. Edition approved for publication 31 March 2010 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2010 by ASD-STAN prEN

7、9137:2010 (E) 2 Contents Page Foreword2 1 Introduction3 2 Normative references 3 3 General guidance.3 4 Detailed guidance 4 Foreword This standard was reviewed by the Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-S

8、TAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significa

9、nt improvements in quality and reductions in cost throughout the value stream. This standard has been developed under the auspices of the IAQG Defence Relationship Growth Strategy Stream and in collaboration with the North Atlantic Treaty Organization (NATO) AC/327, Working Group 2 (WG2) to provide

10、guidance on how the requirements of AQAP 2110 and EN 9100 can be fulfilled by one common Quality Management System. This guidance document has been prepared jointly by the IAQG and NATO, and the content of this standard is identical to AQAP 2009 Annex F from this point onwards. RATIONALE This is the

11、 initial release of this standard. This standard is intended to provide guidance and assist an organization in the use and understanding of the relationship between AQAP 2110 and EN 9100. prEN 9137:2010 (E) 3 1 Introduction 1.1 This document has been prepared and issued to provide information and gu

12、idance on the application of AQAP 2110 when the Supplier adheres to the provisions of EN 9100. This document is published as AQAP 2009 Annex F and 9137. It was jointly developed by NATO and industry representatives for use by NATO and industry to facilitate the use and understanding of the relations

13、hip between the AQAP 2110 and EN 9100. 1.2 It aims to contribute to commonality of interpretation of the AQAP 2110 requirements by the Acquirer and their EN 9100 Supplier. 1.3 Its content has no legal or contractual status nor does it supersede, add to, or cancel any of the AQAP 2110 or EN 9100 requ

14、irements. 1.4 Because of the multiplicity of conditions that can exist (dependent on such factors as the type of work or process, the devices used, and the skill of personnel involved), this guidance should not be considered as all-encompassing nor should it be considered as imposing specific means

15、or methods for meeting contract requirements. Stakeholders should be aware that other means or methods could be used to meet these requirements. 1.5 Users of this guidance should keep in mind that the requirements of AQAP 2110 are mandatory, as cited in the contract, on Suppliers and Sub-suppliers.

16、2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100, Quality Managemen

17、t Systems Requirements for Aviation, Space and Defence Organizations AQAP 2009 Edition 3, NATO Guidance on the Use of the AQAP 2000 Series AQAP 2070 Edition 2, NATO Mutual Government Quality Assurance (GQA) Process AQAP 2110 Edition 3, NATO Quality Assurance Requirements for Design, Development and

18、Production AQAP 2120 Edition 3, NATO Quality Assurance Requirements for Production AQAP 2130 Edition 3, NATO Quality Assurance Requirements for Inspection and Test ISO 9001:2008, Quality management systems Requirements ISO 10012:2003, Measurement management systems Requirements for measurement proce

19、sses and measuring equipment 3 General guidance 3.1 In an EN 9100 certificated organization, the entire content of both standards is within the purview of Government Quality Assurance (GQA). 3.2 When reviewing the two documents (i.e. AQAP 2110, EN 9100) it is helpful to note the differences in wordi

20、ng used to describe the stakeholders. The following equivalence (see Table 1) is offered as a workable translation. The contract will normally define the points of contact, outlining their role and authority. prEN 9137:2010 (E) 4 Table 1 AQAP 2110 and EN 9100 stakeholder terms AQAP 2110 EN 9100 Acqu

21、irer Customer, only if it is the Acquiring government. Government Quality Assurance Representative (GQAR) A Customers Quality Representative. Supplier Organization with a direct contract with the government. Sub-supplier Supplier or Organization without a direct contract with the government. 3.3 EN

22、9100 is complementary (not alternative) to contractual and applicable law and regulatory requirements. It includes ISO 9001:2008 Quality Management System (QMS) requirements and specifies additional requirements for a quality management system for the aviation, space and defence industries. 3.4 The

23、common ISO 9001:2008 baseline inherently makes EN 9100 and AQAP 2110 appear almost identical. However, four features differentiate the two documents: a) AQAP 2110 defines contractual requirements; while EN 9100 defines organizational provisions to be addressed within the scope of certification; b) A

24、QAP 2110 reflects the agreement between NATO members to contract using the mandatory QMS clauses that enables reciprocal GQA; while industry conformance to EN 9100 is voluntary; c) The additions to ISO 9001:2008 of both documents add higher level quality management functions. AQAP 2110 also includes

25、 additional requirements related to communication and GQAR access to contract pertinent facilities, information and processes; d) EN 9100 can be tailored by exclusions, according to the scope of the QMS; whereas AQAP 2110 is pre-tailored into AQAP 2120 and AQAP 2130. 3.5 It is acceptable for a Suppl

26、ier to offer a QMS that complies with the provisions of EN 9100 as a satisfactory response to the QMS requirements of AQAP 2110, under two conditions: a) The Supplier formally states that, “All EN 9100 requirements applicable to the organization are applicable to this contract”; b) The Supplier form

27、ally states that, “No exclusions to EN 9100 taken by the organization shall in any way diminish, alter, or relieve the AQAP 2110 requirements of this contract”; These formal statements could be made in tender documentation, the contract, or the Quality Plan (QP) and should always be brought to the a

28、ttention of the GQAR. 4 Detailed guidance Detailed guidance is provided only where there is either the need for clarification or the potential for conflict or misunderstanding exists. Each paragraph and sub-paragraph of the standards (i.e., EN 9100, AQAP 2110) are listed below in Table 2 EN 9100 and

29、 AQAP 2110 Detailed harmonization guidance. Where either standard contains additional requirements or notes to the base standard (i.e. ISO 9001:2008), the clause heading text is bolded. prEN 9137:2010 (E) 5 Table 2 EN 9100 and AQAP 2110 detailed harmonization guidance EN 9100 CLAUSE AQAP 2110 CLAUSE

30、 DETAILED HARMONIZATION GUIDANCE 4.quality management system 4.0 Quality management system 4.1 General Requirements 4.1 General requirements The Acquirer has chosen the Supplier based in part, on their EN 9100 QMS. With respect to the NATO specific requirements: EN 9100 highlights the need to includ

31、e customer and applicable statutory and regulatory requirements in the scope of the QMS in addition to the 9001 provisions relating to the product (see 7.2.1). The Acquirer and/or GQAR have the right to review and verify that the QMS meets the certification and contractual requirements. Where object

32、ive evidence of non-compliance is presented, the Supplier is obliged to take corrective action. If corrective action is not taken or is shown to be persistently ineffective then ultimately the QMS might be rejected, but this is neither a desired or common outcome. Sharing details of EN 9100 certific

33、ation results from the Online Aerospace Supplier Information System (OASIS) and audit reports provides ongoing evidence of how the system is meeting the certification requirements and may reduce the need for the Acquirer/GQAR to conduct additional audits. 4.2 Documentation Requirements 4.2 Documenta

34、tion requirements 4.2.1 General 4.2.1 General 4.2.2 Quality Manual 4.2.2 Quality manual In EN 9100 exclusions can be made based on the processes within the organization. Such exclusions are permissible as long as they match the tailoring criteria of the AQAP series as shown in AQAP 2009 Figure 2. Wi

35、th reference to AQAP 2110 clause 5.4 it is permissible to detail any interpretational clarifications or specific application of AQAP requirements in the QP. 4.2.3 Control of Documents 4.2.3 Control of documents 4.2.4 Control of Records 4.2.4 Control of records 5.Management responsibility 5.0 Managem

36、ent responsibility 5.1 Management Commitment 5.1 Management commitment 5.2 Customer Focus 5.2 Customer focus 5.3 Quality Policy 5.3 Quality policy prEN 9137:2010 (E) 6 EN 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 5.4 Planning 5.4 Planning Both EN 9100 and AQAP 2110 require plannin

37、g for quality to be undertaken and recorded, describing how the product will be realized (reference 7.1). AQAP 2110 requires a contract specific QP be documented and provided to the Acquirer so that it may be reviewed against the contractual requirements. The QP describes the application of the QMS

38、to fulfill the contract requirements; describing what the Supplier will actually do (e.g. what requirements apply or how they are interpreted). To be compliant, QPs should address clause 5.4 of AQAP 2110 and clause 7.1 of both standards. QPs should be developed in conjunction with other project rela

39、ted planning (reference to EN 9100 clause 7.1.1). 5.4.1 Quality Objectives 5.4.1 Quality objectives 5.4.2 Quality Management System Planning 5.4.2 Quality Management system planning 5.5 Responsibility, Authority and Communication 5.5 Responsibility, authority and communication 5.5.1 Responsibility a

40、nd Authority 5.5.1 Responsibility and authority 5.5.2 Management Representative 5.5.2 Management representative AQAP 2110 requires that the management representative reports directly to top management. EN 9100 requires that the management representative has unrestricted access to top management. The

41、 key aspect is that AQAP 2110 requires the management representative to have the necessary organizational authority and freedom to resolve matters pertaining to the QMS and product quality. In that respect, the standards are considered to be in harmony. 5.5.3 Internal Communication 5.5.3 Internal co

42、mmunication The NATO Specific requirement for communication with the GQAR should be considered as part of EN 9100 clause 7.2.3 customer communication. 5.6 Management Review 5.6 Management review 5.6.1 General 5.6.1 General 5.6.2 Review Input 5.6.2 Review input 5.6.3 Review Output 5.6.3 Review output

43、 6. Resource management 6.0 Resource management 6.1 Provision of Resources 6.1 Provision of resources 6.2 Human Resources 6.2 Human resources prEN 9137:2010 (E) 7 EN 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 6.2.1 General 6.2.1 General 6.2.2 Competence, Awareness and Training 6.2.

44、2 Competence, awareness and training 6.3 Infrastructure 6.3 Infrastructure 6.4 Work Environment 6.4 Work environment 7. Product realization 7.0 Product realisation 7.1 Planning of Product Realization 7.1 Planning of product realisation 7.1.1 Project Management 7.1.2 Risk Management 7.1.3 Configurati

45、on Management The EN 9100 additional requirement should be viewed in conjunction with AQAP 2110 clause 7.7. 7.1.4 Control of Work Transfers With respect to the EN 9100 additional requirement, work transfers include transfers within and outside of the organization. 7.2 Customer-Related Processes 7.2

46、Customer-related processes 7.2.1 Determination of Requirements Related to the Product 7.2.1 Determination of requirements related to the product 7.2.2 Review of Requirements Related to the Product 7.2.2 Review of requirements related to the product 7.2.3 Customer Communication 7.2.3 Customer communi

47、cation The NATO Specific requirement for communication with the GQAR includes the NATO specific requirement in AQAP 2110 clause 5.5.3 Internal communication. 7.3 Design and Development 7.3 Design and development 7.3.1 Design and Development Planning 7.3.1 Design and development planning 7.3.2 Design

48、 and Development Inputs 7.3.2 Design and development inputs 7.3.3 Design and Development Outputs 7.3.3 Design and development outputs 7.3.4 Design and Development Review 7.3.4 Design and development review The authorization referred to in EN 9100 for progressing to the next stage in design and devel

49、opment is the Suppliers process and should not be confused with Acquirer intermediate or final acceptance of product. 7.3.5 Design and Development Verification 7.3.5 Design and development verification prEN 9137:2010 (E) 8 EN 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 7.3.6 Design and Development Validation 7.3.6 Design and development validation 7.3.6.1 Design and/or development verification and validation testing Within EN 9100 prove means to demonstrate o